Going in for surgery is almost always fraught with anxiety and fear. Few people, though, would ever think that the risks of surgery included the possibility of their bones catching on fire.
Sadly, a defective medical product has made this a real possibility. Earlier this summer, the U.S. Food and Drug Administration asked Johnson & Johnson to recall several lots of hemostatic bone putty out of fears that the putty could catch on fire if it came into contact with some surgical instruments. The putty is designed to stop bones from bleeding when they have been damaged in an accident or cut during surgery.
The recall was designated as a Class I by the FDA, which is the most serious recall classification.
This specific type of bone putty, manufactured by a division of Johnson & Johnson called Synthes, was recalled in early July. At that time, the manufacturer asked medical facilities to immediately discontinue use of the product. The problematic lots were distributed between December 2011 and July 2012.
The $19.7 billion purchase of medical device maker Synthes was completed by Johnson & Johnson in June. Johnson & Johnson has been involved in several other high-profile product recalls, including hip implants, contact lenses, and popular over-the-counter medications.
Dangerous Medical Devices
No patient should ever have to worry whether a particular medical device is safe. Unfortunately, negligence in the manufacturing or design process can render a product unreasonably dangerous. Too often, these dangers aren’t recognized until someone is grievously injured.
People who are injured by dangerous medical devices have a right to take action against the manufacturer for the harm that was done to them.
Source: Fox Business, “FDA: J&J Unit Recalls Potentially Flammable Bone Putty,” August 21, 2012.
To learn more about this issue, please visit our defective medical devices page.